Novo Nordisk's etavopivat, acquired from Forma Therapeutics in a $1.1B buyout, is the first in a new class of drugs to meet both co-primary endpoints in the Phase 3 HIBISCUS trial for sickle cell disease (SCD). 1
Etavopivat substantially improves hemoglobin levels and reduces pain crises in SCD patients.135
Novo Nordisk plans regulatory submission in the second half of 2026, targeting FDA approval via a 10-month priority review.3
Etavopivat targets red blood cell metabolism to enhance oxygen-carrying capacity, differing from standard SCD treatments.5
Sources:
1. https://www.nasdaq.com/press-release/novo-nordisk-etavopivat-first-new-class-drugs-meet-both-co-primary-endpoints-phase-3
3. https://www.ainvest.com/news/novo-nordisk-etavopivat-phase-3-win-creates-term-regulatory-catalyst-2026-submission-2604/
5. https://www.withpower.com/trial/phase-3-anemia-sickle-cell-11-2024-eab70